Quetiapine
- Product NDC
- 42291-695
- 11-digit product format
- 422910695
- Labeler code
- 42291
- Product ID
- 42291-695_4871de67-6df0-716d-e063-6394a90a2195
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Quetiapine
- Dosage form
- TABLET, FILM COATED
- Route
- ORAL
- Labeler
- AvKARE
- Application
- ANDA077745
- Marketing category
- ANDA
- Marketing start
- 2022-05-25
- Marketing end
- 2026-06-30
- Substance
- QUETIAPINE FUMARATE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Atypical Antipsychotic [EPC]
- NDC exclude flag
- No
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Quetiapine
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| QUETIAPINE FUMARATE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2S3PL1B6UJ |
| Rxcui | 312743, 312744, 312745, 317174, 616483, 616487 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 42291-695-10 | Quetiapine | 1000 in 1 BOTTLE | TABLET, FILM COATED | 1000 | | 12 |
| 42291-695-90 | Quetiapine | 90 in 1 BOTTLE | TABLET, FILM COATED | 90 | | 12 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| QUETIAPINE FUMARATE | ACTIVE INGREDIENT | 2S3PL1B6UJ | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| QUETIAPINE | ACTIVE MOIETY | BGL0JSY5SI | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| ALUMINUM OXIDE | INACTIVE INGREDIENT | LMI26O6933 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE | INACTIVE INGREDIENT | O7TSZ97GEP | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| CELLULOSE, MICROCRYSTALLINE | INACTIVE INGREDIENT | OP1R32D61U | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| FD&C YELLOW NO. 6 | INACTIVE INGREDIENT | H77VEI93A8 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| FERRIC OXIDE YELLOW | INACTIVE INGREDIENT | EX438O2MRT | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| HYPROMELLOSE 2910 (15 MPA.S) | INACTIVE INGREDIENT | 36SFW2JZ0W | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| HYPROMELLOSE 2910 (3 MPA.S) | INACTIVE INGREDIENT | 0VUT3PMY82 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| HYPROMELLOSE 2910 (50 MPA.S) | INACTIVE INGREDIENT | 1IVH67816N | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| HYPROMELLOSE 2910 (6 MPA.S) | INACTIVE INGREDIENT | 0WZ8WG20P6 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| LACTOSE MONOHYDRATE | INACTIVE INGREDIENT | EWQ57Q8I5X | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| MAGNESIUM STEARATE | INACTIVE INGREDIENT | 70097M6I30 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| POLYDEXTROSE | INACTIVE INGREDIENT | VH2XOU12IE | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| POLYETHYLENE GLYCOL 8000 | INACTIVE INGREDIENT | Q662QK8M3B | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| POVIDONE K25 | INACTIVE INGREDIENT | K0KQV10C35 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| POVIDONE K26/28 | INACTIVE INGREDIENT | H7AGY1OJO8 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| SILICON DIOXIDE | INACTIVE INGREDIENT | ETJ7Z6XBU4 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| SODIUM STARCH GLYCOLATE TYPE A POTATO | INACTIVE INGREDIENT | 5856J3G2A2 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
| TRIACETIN | INACTIVE INGREDIENT | XHX3C3X673 | QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) TABLET, FILM COATED [AVKARE, INC.] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 42291-695 | QUETIAPINE TABLET, FILM COATED [AVKARE] | 11 | Current NDC, Legacy NDC, 2 package rows | 20230117_8a3fc038-aad1-6404-6ead-a4a55127cf43.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 42291-695-10 | 42291069510 | 1000 TABLET, FILM COATED in 1 BOTTLE (42291-695-10) | 2022-05-25 | 2026-06-30 | No | No | Current |
| 42291-695-90 | 42291069590 | 90 in 1 BOTTLE | | | | | Historical |